Can a drug be classified as both adulterated and misbranded?

A drug can indeed be classified as both adulterated and misbranded, and this classification acknowledges that the drug meets the criteria for more than one violation under the law.

To understand this, it's essential to define both terms briefly. Adulteration refers to conditions that affect the drug's purity or quality, such as being contaminated with substances that render it unsafe or ineffective. Misbranding, on the other hand, involves issues related to labeling, such as misleading information or failure to include necessary warning labels.

When a product is found to be adulterated, it indicates a compromise in product integrity, while misbranding points to failures in communication and transparency regarding the drug's contents or usage. Therefore, a drug can easily encompass violations from both categories, reflecting the complexities in how pharmaceutical products can fail to meet regulatory standards. This dual classification highlights the importance of adherence to both manufacturing practices and accurate labeling to ensure consumer safety and proper medication use.